Principles and regulatory pathways of exosome-based products in wound healing: Insights from the Iranian Food and Drug Organization Guideline

Wound healing is a critical clinical challenge, particularly for chronic and refractory wounds complicated by infection, necrosis, amputation, and death. Recently, cell derivatives, particularly extracellular vesicles (EVs) from mesenchymal stem cells, have emerged as promising cell-free therapeutic agents in regenerative medicine. The review aims to introduce small extracellular vesicles (sEVs) as a next-generation therapeutic strategy and to describe different EV types according to the Global Regulatory Framework (GRF). We also compare techniques for isolating, purifying, and characterizing sEVs and evaluate sEV-based therapies in tissue engineering, focusing on their scope and limitations.A narrative review of the literature was conducted, focusing on preclinical and clinical studies investigating EV-based therapies in wound healing, along with an investigation of the GRF, particularly the Iranian Food and Drug Administration (IFDA) guideline on EVs. The IFDA has recently established a framework for categorizing extracellular particles and highlighting the structural complexity and functional diversity of EVs. sEVs demonstrate significant therapeutic potential for wound repair by promoting angiogenesis, enhancing epithelialization, modulating inflammation, and accelerating tissue remodeling. To enhance the stability and therapeutic lifespan of sEVs, advanced delivery systems, including hydrogels, nanofibers, and biomatrices, are used to preserve structural integrity, physicochemical stability, biological functionality, and morphological characteristics, and to control their release at the injury site. EV-based therapies represent a promising and versatile approach in regenerative medicine for wound healing. Despite challenges in isolation, characterization, scalable manufacturing, and regulatory approval, sEV-based therapeutics offer a biocompatible, cost-effective, and versatile platform that bridges nanotechnology and regenerative medicine.

کلیدواژه ها:

Biological Products ، Drug approval ، Exosomes ، Extracellular vesicles ، Government regulation ، Nanomedicine ، Regenerative medicine ، Wound healing